FDA

Guidance

implement recommendation and clarify statutory provision

Existing and non existing regulation Guidance Statutory enactment Report/ review of FDA

regulatory science challenge

Statutory enactment

require science-based practice, may need rulemaking, guidance or analysis/support

Preclinical testing

researchers must determine the potential rist for toxicity utilizing in vitro and in vivo studies before testing a drug on people

Clinical research

studies conducted in human to determine the safety and efficiency of a potential drug

Phase 2

Determine efficacy and side effects in patients

dosage and administration

Bases on administration in phase 3

Dietary supplements Bottled water Food additives infant formula

CFSAN regulates food including

Phase 1

Characterize drug in the human safety profile and dosage for Phase 11

Formulation dosage strength route adminstration dosage form device component product line extension

Chemistry and design of a Drug must contain

Terfenadine Cisapride Cervistain

Drugs that have been withdrawn

Science based decision making Leveraging Enforcement transparency

FDA Basic working principles

Phase 1 and 2 before any phase 3

FDA and Sponsors start to discuss drug development

Medical Practice Medical service Price of medical products

FDA does not dictate

Advertising Alcohol Consumer products Drugs of Abuse Health Insurance Meat and Poultry/Eggs Pesticides Restaurants and grocery stores water

FDA does not regulate

Regulation tobacco products Helping to speed innovations that make medicine and food more effective/safer Helping the public get accurate information they need to use medicines and food

FDA is also responsible for advancing the public health by

Bioterroism Flue Food pathogens antibiotic resistance Bis-phenol A Drug re-importation Counterfeit drugs Gene therapy Hormone replacement therapy stem cell research personalized medicine biomarkers

FDA issues

Protect and promote the public health Consumer protection agency Regulatory agency

FDA mission

Bulk maufacturing Packaging Labeling Quality controls

Manufacturing and controls of a drug contains

Responsible for protection of consumers by ensuring compliance inspection of regulated products

ORA does what

Discovery and screening

Researcher discover a potential drug candidate and preform preliminary test to evaluate and characterize the drug

Food Drugs Dietary Supplements Vaccines/ Blood Animal Food and Drugs Biotechonolgy toxicological research Medical Devices/ Radiology Cosmetics Tobacco products

Scope of FDA's Mission

assure that proposed human trial do not place humans at unreasonable risk verifies sufficient informed consent verifies human subject protection

What does the FDA review of the IND

Chemical structure proposed method of action preclinical work an anticipated side effect any issue with manufacturing Detailed clinical plan

What is an IND

Existing and non-existing regulation

adapting to considering new scientific methods may mean new rule making

adverse reaction

based on events reported in all clinical studies

clinical efficacy

based on the outcomes of phase 3

Phase 3

confirm efficacy and monitoring of adverse reaction

clinical pharmacology

mechanism of acition, pharmacodynamic, pharmacokinetics from phase 1 and 2 studies

indication

patient population and disease tested

Serious disease unmet medical need surrogate endpoint rolling submission

what can happen with and accelerated approval

Stop the trial at anytime must receive regular updates side effects negative results highly positive results

what can the FDA do in clinical trials

Advances regulatory science research Promotes global interactions fosters scientific training

what does NCTR do

FDA has 60 days CDER team is assigned to review FDA inspects manufacturing site one year for a new drug review

what happens when NDA is submitted

sponsor submit periodic updates monitor for side effects

what is a post marketing safety system

Multiple species of animals must be tested IND submitted to FDA FDA review within 30 days IND is open and in effect

what is done before clinical trials can start

All materials from IND Additional non-human studies since IND all human data How drug behaves in the body Drug chemistry, manufacturing and controls

what is the NDA

meets with sponsor before NDA is submitted

what must happen before NDA is submitted

CDER sponsor Team of scientist Physicians Biochemist statisticians pharmacologist......

who evaluates the NDA